Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia.
N Toft, H Birgens, J Abrahamsson...
https://pubmed.ncbi.nlm.nih.gov/28819280Actively Recruiting
Age: 0Years - 45Years
All Genders
ID03911128
A Treatment Study Protocol of the ALLTogether Consortium for Infants, Children and Young Adults (0-45 Years) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL): a Pilot Study
Led by Mats Heyman · Updated on 2025-09-02
500
Participants Needed
53
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mats Heyman
Lead Sponsor
N
Nordic Society for Pediatric Hematology and Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a master protocol designed to improve survival and quality of life for infants, children, and young adults aged 0 to 45 years who have been newly diagnosed with acute lymphoblastic leukemia (ALL). This observational pilot study collects data from multiple well-known study groups, combining their experience into a comprehensive system for stratifying and treating ALL within this age group. The study aims to optimize diagnostics, registration systems, and collaborative logistics before the main study begins, focusing on standard of care treatments included in the master protocol. The study does not involve specific experimental interventions but serves as a platform for personalized risk-based diagnosis and treatment approaches. It includes standard treatments delivered at participating pediatric oncology or adult hematology centers in the involved countries. High-risk patients may be considered for specialized therapies such as Chimeric Antigen Receptor T-cell (CAR-T) therapy as an alternative to more intensive treatments to reduce side effects. The platform supports randomized and non-randomized interventions and translational research within the collaboration. Participants will be monitored through regular clinical assessments, with data collected on event-free survival and overall survival compared to historical controls over five years. The study involves confirmation of diagnosis by accredited laboratories, ongoing treatment at participating centers, and adherence to protocol procedures. This pilot phase focuses on collecting data and preparing the infrastructure for future randomized trials and extended research. Participants remain under their usual care throughout the study period, which spans several years for outcome evaluation.
CONDITIONS
Brief Title
A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
Who Can Participate
Age: 0Years - 45Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) confirmed by an accredited laboratory
- Age 0 up to but not including 46 years at diagnosis
- Patients with surface immunoglobulin negative BCP-ALL with IG::MYC rearrangement unless concurrent BCL2/6 rearrangement present
- Signed informed consent by patient and/or parents/legal guardians as per country guidelines
- Diagnosis and treatment at participating pediatric oncology or adult hematology centers
- Resident or intending to reside permanently in a participating country
- Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to treatment start
You will not qualify if you...
- Infants under 1 year with KMT2A-rearranged BCP-ALL
- Age above 45 years at diagnosis
- Previous malignant diagnosis including ALL as a second malignancy
- Relapsed ALL
- Mature B-ALL or patients with IG::MYC and concurrent BCL2/6 rearrangement
- Philadelphia chromosome positive ALL (t(9;22) or BCR::ABL1 fusion)
- Known ALL prone syndromes except Down syndrome
- Systemic corticosteroid treatment over 10mg/m2/day for more than one week or chemotherapy within 4 weeks prior to diagnosis
- Contraindications preventing adequate treatment
- Conditions interfering with compliance or participation
- Pregnant or breastfeeding women
- Women and fertile men unwilling to use effective contraception during therapy
- Missing essential diagnostic data as determined by protocol chair
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 5 years
Participants with newly diagnosed acute lymphoblastic leukaemia are observed under a personalised risk-based protocol to monitor disease progression and treatment outcomes.
Regular visits scheduled as part of routine clinical care
Trial Site Locations
Total: 53 locations
1
Aalborg University Hospital, Dept of Paediatrics
Aalborg, Denmark, 9000
Active, Not Recruiting
2
Aarhus University Hospital
Aarhus, Denmark, 8000
Active, Not Recruiting
3
Aarhus University Hospital, Child and Adolescent Health
Aarhus, Denmark, 8200
Active, Not Recruiting
4
Rigshospitalet, Dept of Haematology
Copenhagen, Denmark, 2100
Active, Not Recruiting
5
Rigshospitalet, Dept of Paediatrics
Copenhagen, Denmark, 2100
Active, Not Recruiting
6
Odense University Hospital, Dept of Paediatrics
Odense, Denmark, 5000
Active, Not Recruiting
7
North Estonia Medical Centre, Dept of Haematology
Tallinn, Estonia, 13419
Not Yet Recruiting
8
Tallinn Children´s Hospital, Dept of Paediatrics
Tallinn, Estonia, 13419
Not Yet Recruiting
9
Tartu University Hospital
Tartu, Estonia, 50406
Not Yet Recruiting
10
Helsinki University Hospital, Dept of Haematology
Helsinki, Finland, 00029
Active, Not Recruiting
11
Helsinki University Hospital, Dept of Paediatrics
Helsinki, Finland, 00029
Active, Not Recruiting
12
Kuopio University Hospital, Dept of Haematology
Kuopio, Finland, 70029
Active, Not Recruiting
13
Kuopio University Hospital, Dept of Paediatrics
Kuopio, Finland, 70029
Active, Not Recruiting
14
Oulu University Hospital, Dept of Haematology, Dept of Medicine
Oulu, Finland, 90029
Not Yet Recruiting
15
Oulu University Hospital, Dept of Paediatrics
Oulu, Finland, 90029
Active, Not Recruiting
16
Tampere University Hospital, Dept of Haematology
Tampere, Finland, 33521
Not Yet Recruiting
17
Tampere University Hospital, Dept of Paediatrics
Tampere, Finland, 33521
Active, Not Recruiting
18
Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit
Turku, Finland, 20520
Not Yet Recruiting
19
Turku University Hospital, Dept of Paediatrics
Turku, Finland, 20520
Active, Not Recruiting
20
Landspitali University Hospital, Children's Hospital
Reykjavik, Iceland, 101
Active, Not Recruiting
21
Children's Hospital, Affiliate of Vilnius University Hospital
Vilnius, Lithuania, 08406
Active, Not Recruiting
22
Vilnius University Hospital
Vilnius, Lithuania, 08661
Active, Not Recruiting
23
Haukeland University Hospital, Dept of Haematology
Bergen, Norway, 5021
Active, Not Recruiting
24
Haukeland University Hospital, Dept of Paediatrics
Bergen, Norway, 5021
Active, Not Recruiting
25
Oslo University Hospital, Dept of Haematology
Oslo, Norway, 0372
Active, Not Recruiting
26
Oslo University Hospital, Dept of paediatric haemato- and oncology
Oslo, Norway, 0424
Active, Not Recruiting
27
Stavanger University Hospital, Dept of Haematology
Stavanger, Norway, 4011
Active, Not Recruiting
28
University Hospital North Norway, Dept of Haematology
Tromsø, Norway, 9019
Active, Not Recruiting
29
University Hospital of North Norway, Dept of Paediatrics
Tromsø, Norway, 9038
Active, Not Recruiting
30
St. Olavs University Hospital, Dept of Paediatrics
Trondheim, Norway, 7006
Active, Not Recruiting
31
St. Olavs University Hospital, Dept of Haematology
Trondheim, Norway, 7030
Active, Not Recruiting
32
Hospital Universitario de Cruces
Barakaldo, Spain
Actively Recruiting
33
Hospital Universitario San Joan de Déu
Barcelona, Spain
Actively Recruiting
34
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Actively Recruiting
35
Hospital Universitario La Paz
Fuencarral-El Pardo, Spain
Actively Recruiting
36
Hospital Infantil Universitario Nino Jesus
Madrid, Spain
Actively Recruiting
37
Hospital Universitario Son Espases
Palma de Mallorca, Spain
Actively Recruiting
38
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
39
Hospital Universitario Politécnico La Fe
Valencia, Spain
Actively Recruiting
40
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
41
Sahlgrenska University Hospital, Section for Haematology and coagulation
Gothenburg, Sweden, 41345
Active, Not Recruiting
42
Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology
Gothenburg, Sweden, 41685
Active, Not Recruiting
43
Linköping University Hospital, Dept of Haematology
Linköping, Sweden, 58185
Active, Not Recruiting
44
Linköping University Hospital, Dept of Paediatrics
Linköping, Sweden, 58185
Active, Not Recruiting
45
Skåne University Hospital, Dept of Haematology
Lund, Sweden, 22185
Active, Not Recruiting
46
Skåne University Hospital, Dept of Paediatrics
Lund, Sweden, 22185
Active, Not Recruiting
47
Örebro University Hospital, Section for Haematology
Örebro, Sweden, 70185
Active, Not Recruiting
48
Karolinska University Hospital, Dept of Paediatric Oncology and Haematology
Stockholm, Sweden, 17176
Active, Not Recruiting
49
Karolinska University Hospital, Patient area Haematology
Stockholm, Sweden, 17176
Active, Not Recruiting
50
Norrland University Hospital, Dept of Haematology
Umeå, Sweden, 90185
Active, Not Recruiting
51
Norrland University Hospital, Dept of Paediatrics
Umeå, Sweden, 90185
Active, Not Recruiting
52
Uppsala University Hospital, Dept of Haematology
Uppsala, Sweden, 75185
Active, Not Recruiting
53
Uppsala University Hospital, Dept of Paediatric Haematology and Oncology
Uppsala, Sweden, 75185
Active, Not Recruiting
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Research Team
T
Trial Central Office
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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